PSD ANALYSIS BY MALVERN INSTRUMENT
At Microfine we provide Particle Size Distribution (PSD) report by laser diffraction method using Malvern Instrument. Depending on the customers requirement we provide reports by dry or wet method.
Our in-house design of Air Jet Mill ensures particle size reduction up to or even less than 5 microns for most of the products with huge volumes.
MICRONIZATION OF APIS
At Microfine we offer services of contract microniztion of APIs following cGMP standards with complete particle size analytical support and process validation as per customer’s required particle size specification. Microfine has an expertise to micronize large volumes in a short time frame with its large capacity and four dedicated micronizing streams.
The facility is conveniently located at the well developed industrial township in GIDC (Gujarat Industrial Development Corporation), Vapi, Gujarat, India (City/State/Country) which is about 186 km North of Mumbai city on the national highway NH-8. The distance of the plant from Vapi railway station/town is around 2 km.
The site is spread over total land area of 1740 sq. meters with a built up area of 940.48 sq. meters. The site is well planned with independent AHUs and appropriate pressure gradients that ensures contamination free environment.
To ensure the smooth running of the manufacturing operations the facility is laid out as per cGMP guidelines with segregated block and areas like:
- Administration Block
- Production Block
- Utility Area
- Raw material Storage Area
- Packaging material Storage Area
- Finished Goods Storage Area
- Washing Area
The production block has three manufacturing streams (I, II, III) and one pilot stream (IV). Each stream is independent and has dedicated sections for milling, packing, and quarantine. These are ably supported by adequate service departments like Warehouses, Engineering, Quality Assurance and Quality Control. There is separate entry for movement of man and material.
The equipment installed conforms to Current Good Manufacturing Practice (cGMP) requirements.
All processes related to micronization of Active Pharmaceutical Ingredients (API) including, packaging, and test by the quality control laboratory are carried on at the site.